Vaccine Effectiveness: Clinical Trial in a Well™

The MIMIC® System is a "Clinical Trial in a Well™" for vaccines. With it, we can predict the effectiveness of different adjuvants and antigens, as well as dosing and timing of administration. We can also predict cross-protection against other strains, determine the potency of stockpiled vaccines, and compare the effects of different manufacturing methods on vaccine potency.

This application uses the Peripheral Tissue Equivalent (PTE) module and Lymphoid Tissue Equivalent (LTE) module to generate an immune response to the candidate vaccine. We then perform functional assays or a Disease Model module to determine the effectiveness of the immune response against the strain of interest and, if desired, cross-protection against other strains. These studies typically use cells from 20–50 donors with diverse attributes to represent a target population.

Different analyses may be performed at various stages and time periods in the study. For example, the following analyses are available for influenza vaccine studies:

  • concentrations of cytokines and other biological molecules;
  • phenotypes of cells and their prevalence;
  • antibody production
  • hemaagglutination inhibition;
  • viral neutralization;
  • CTL responses
  • T cell responses
  • T cell cross-reactivity
  • B cell cross-reactivity
  • antibody avidity indices

In addition to standard analytical methods, the VaxDesign Campus has developed a battery of proprietary functional assays with greater sensitivity and shorter timelines than the standard assays. Examples include surface assisted HAI assays, fluorescence-based viral microneutralization assays, and massively parallel cross-reactivity and antibody avidity assays.

As an example, a Clinical Trial in a Well™ for influenza may encompass pre-existing influenza exposure (circulating antibodies), safety (reactogenicity and auto-antibodies), and the quantity, quality, and functionality (HAI and microneutralization assays) of influenza-specific immune responses. Sanofi Pasteur VaxDesign Campus has conducted all of these studies, most with proprietary assays. See Case Studies for influenza vaccine Clinical Trial in a Well™ results.

The timeline for this type of study is 6–9 months. The cost of the study depends on the scope of the project and the analysis needed.